CLASS II ONGOING Device recall · Reported 25 Mar 2026 · FDA Enforcement Report
ID NOW" Influenza recalled by Abbott Diagnostics Scarborough
Abbott Diagnostics Scarborough is recalling ID NOW" Influenza A & B 2, distributed nationwide in the US. The recall was initiated on 9 Feb 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1565-2026
- FDA event ID
- 98400
- Recalling firm
- Abbott Diagnostics Scarborough, Scarborough, ME
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Feb 2026
- FDA classified
- 13 Mar 2026
- Reported
- 25 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Feb 2026 | Recall initiated by company | |
| 13 Mar 2026 | Classified by FDA | +32 days |
| 25 Mar 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Which lots are affected?
List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Abbott Diagnostics Scarborough
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Id Now Covid-19 2.0 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Device Malfunction | Nationwide |
| Device | CLASS II | Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
| Device | CLASS II | Id Now Covid-19 2.0 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Device Malfunction | Nationwide |
| Device | CLASS II | ID NOW Influenza A/B 2 24T recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
| Device | CLASS II | Id Now Rsv 24t recalled by Abbott Diagnostics Scarborough | Abbott Diagnostics Scarborough | Potency & Assay | Nationwide |
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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |